Drug Safety And Pharmacovigilance


Published on

This training course on Drug Safety and Pharmacovigilance designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance.

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Drug Safety And Pharmacovigilance

  1. 1. Net Zealous India Seminar 2012 at Mumbai USFDA & EU ESSENTIALS OF DRUG SAFETY AND PHARMACOVIGILANCE by Steve Jolley On 5th, 6th and 7th March, 2012 at Mumbai at InterContinental The LalitAbout GlobalCompliancePanel:GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of highquality regulatory and compliance-related services.At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances,Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which wehave successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of thesesessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collectiveexperience are associated with us.Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and ITControl & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for groupviewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such asJ&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
  2. 2. India Seminar 2012 at Mumbai Steve Jolley Principal, SJ Pharma ConsultingAbout Speaker:Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequentspeaker at leading industry events including DIA and MHRA.He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europeand Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is afeatured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining.Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computersystems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB wasacquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.Past Seminars Date and Venue: March 5th, 6th and 7th, 2012 Intercontinental The LaLiT Mumbai Sahar Airport Road Mumbai – 400059 India
  3. 3. India Seminar 2012 at Mumbai Seminar Content: Conference timings: 9:00 am - 6:00 pm Day 1 - 5th March 2012 Day 2 - 6th March 2012 Day 3 - 7th March 2012Lecture 1: Overview of Lecture 5: Inspections and Audits Lecture 9: Background to SignalPharmacovigilance „ Audits vs Inspections Detection„ Learning Objectives for this Session „ Why Conduct Them? „ The need for signal detection„ History of Pharmacovigilance „ Regulatory Requirements „ Types of Audits & Inspections„ Pre-Marketed Aes „ Approach to Signal Detection „ Who Can be Audited? „ Company Characterization„ Post-Marketed Aes„ Pre- and Post-marketing: Basic Differences „ Approaches „ Characteristics of small versus large companies„ The Importance of Adverse Event Reporting „ Preparing for a Pharmacovigilance Inspection „ Premise for Signal Detection„ Pharmacovigilance Definitions „ Importance of astute clinical perspective„ ICH Definition of Adverse Event „ Danger of over-reliance on technology Lecture 6: Pharmacovigilance Best „ Detailed characteristics„ ICH Definition of Adverse Drug Reaction Practices „ Elements of case series analysis„ Suspected Unexpected Serious Adverse Reaction „ Achieving Best Practices through the„ Sources of ADRs Pharmacovigilance Audit „ Lecture 10: Signalling Exercises„ Pharmacovigilance Process „ Value Derived „ Signaling Case Study „ Scope „ Data FlowLecture 2: Assessing Adverse Event „ Pharmacovigilance Process Model „ Recommended data elements to be obtainedCases „ Audit Items - Collection prior to analysis„ Assessing Adverse Events „ Typical PSUR data elements„ Regulatory Definition of a Serious Adverse Event „ Audit Items - Assessment „ Analysis by MedDRA System Organ Class„ Severity/Intensity „ Audit Items - Reporting „ Analysis by MedDRA Preferred Term„ Difficulty Assessing Relationship of AEs with „ Analysis by Age Range „ Audit Items - Analysis Drug „ Analysis by Sex„ Causality „ Additional Audit Items (1) „ Analysis by Country„ Lack of Efficacy -- ICH „ Additional Audit Items (2) „ Analysis by Time to Onset„ Expectedness „ Company Sources of Information to be Examined „ Analysis by Treatment Duration„ Assessing Expectedness/Labeledness/Listedness „ Analysis by AE Duration „ PV Checklist„ Labeled vs. Listed „ Analysis by Concomitant Medications Lecture 7: Preparing for an Inspection „ LectureLecture 3: Reporting Adverse Events 11: Data Mining Exercises „ Pharmacovigilance Risk Profile„ General Types of Reports „ What is Data Mining? „ Priority of Findings „ Principles of Safety Data Mining„ Expedited Reporting – What to Report„ Expedited Reporting – What not to report „ Report Table of Contents „ Challenges in Adverse Event Databases„ Aggregate Reports – Common Types „ Limited Diagnostic Can Initiate The Assessment „ Recommended Approach: Large Company„ Reporting Timeframes for ICSRs „ Components of suggested analyses „ Assessment Approach„ Timelines for Follow-Up „ Discussion of external data sources „ Workflow/Processes-Global „ Pros and cons of different external data sources„ Reporting to IRB/ECs „ Processes-CRO „ Data Flow Elements„ Investigator Notification „ Data Mining Fundamentals„ Minimum Criteria for Reporting „ Data Assessment „ Description of recommended data mining„ Minimum Data Set – Day “0” „ Personnel Qualifications & Training methodologies„ Reporting Format „„ Key Data Elements for Inclusion in Expedited Lecture 8: Case Studies with Real-Life Reports Inspection Findings Lecture 12: Pharmacovigilance and „ Representative Findings from Case Study Risk Management ProcessLecture 4: Global Regulatory „ Pharmacovigilance Process „ Four Case StudiesRequirements „ Signal Detection Operational Questions„ Matrix of Safety Regulations „ Critical Issues Observed „ Signal Detection Sources„ New FDA Regulation for IND safety reporting „ Major Issues Observed „ Signaling Process„ International Conference on Harmonisation (ICH) „ Tips for the Pharmacovigilance Audit „ Signal Evaluation Steps„ ICH Topic Codes and Reports „ Signal Repository and Safety Profiles „ Eight Domains of PhV„ Eudravigilance – Pre-Marketing Requirements „ Product Safety Profile (PSP)* „ Inspection Findings„ Eudravigilance – Post-Marketing Requirements „ Risk Management Planning„ Annual Safety Report „ How to Address Inspection Findings? „ Factors to Consider in Signaling Optimization„ IND Annual Report „ Signal Detection Triage Example„ Development Safety Update Report „ Triage Algorithms Used„ New European Pharmacovigilance Legislation „ Comprehensive Signaling Process Elementswww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
  4. 4. India Seminar 2012 at MumbaiWhat you get:1. Learning Objectives Pricing List:2. Participation certificates 1. Price for One Delegate pass – INR3. Interactive sessions with the US expert 20000 + 10.3% tax4. Post event email assistance to your queries. (Between February 19th to March 4th)5. Special price on future purchase of web based trainings. -----------------------------------------6. Special price on future consulting or expertise services. 2. Early bird price for one Delegate7. Special price on future seminars by GlobalCompliancePanel. pass – INR 18000 + 10.3% tax8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, (Between January 30th to February 18th) notepad and pen. -----------------------------------------9. Networking with industrys top notch professionals 3. Group Delegate pass (5 & above) – 10% discount on total amount. Companies that will benefit: — Drug Companies — Biologic Companies Professionals who will benefit: — CROs £ Drug safety and pharmacovigilance £ Regulatory affairs £ Clinical development £ Executives (including C-Level) with anyHow to Register: legal responsibility for drug safetyStep 1: Download the registration form from GlobalCompliancePanel website. £ Clinical safety staffStep 2: Fill in the requested information and fax us or email a scanned copy of the same. £ Pharmacovigilance specialists £ Regulatory affairs professionalsStep 3: Send us the cheque with the purchase document which comes with the registration form. £ Quality management specialistsStep 4: We will send you a confirmation letter within 1 week after we receive the check. £ Management involved in clinical oversightStep 5: Bring the confirmation letter with you on the 1st day of the seminar and submit it at the registration counter to receive your seminar kit and join the seminar. £ Pharmacovigilance £ Pharmacoepidemiology £ Regulatory affairs Contact Information: Event Coordinator Toll free: 1800 425 9409 Phone number: +91 80-3221-3341 / +91 80-3247-3696 / Kindly get in touch with us for +91 80-3221-3329. any help or information. Email: customersupport@globalcompliancepanel.com Look forward to meeting you GlobalCompliancePanel at the seminar NetZealous Services India Pvt. Ltd. Team GlobalCompliancePanel 4th Floor, A, Block, Brigade Software Park, Banashankari 2nd stage, Bangalore-560070. INDIA. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.